Pharmaceutical company agrees to give sick 7-year-old boy medicine

Josh Hardy will soon receive an experimental drug from pharmaceutical company Chimerix that doctors say will save the ailing 7-year-old’s life. (Hardy Family)

A small North Carolina pharmaceutical company has agreed to provide an ailing 7-year-old boy with medicine that could save his life.

Chimerix announced yesterday that the company is starting a new trial and Josh Hardy will be the first patient to participate.

Josh’s parents Todd and Aimee Hardy received a call from Chimerix president and CEO Kenneth Moch a half-hour before the news was released to the public, according to CNN.

Aimee Hardy expressed her overwhelming elation in a poignant message on her personal Facebook page: “Glory to GOD! They’re releasing the drug for Josh!”

Moch originally refused the Hardy family’s compassionate-use request for its experimental drug Brincidofovir, saying that providing the medication to patients would slow down the Food and Drug Administration’s approval process.

At 9 months, Josh was diagnosed with a rare cancer that effects only 15 kids a year. As a result of his treatments, he developed a bone marrow disorder and last year he underwent chemotherapy and a bone marrow transplant. These treatments led to more complications and in January he was admitted to the ICU for heart failure. Five days later he was put on a ventilator.

Just when Josh was improving, his body became plagued by an adenovirus and doctors treated him with a medicine that damaged his kidneys. His medical team recommended switching to an antiviral medication called Brincidofovir that miraculously cleared up adenovirus in other children.

But getting Brincidofovir isn’t easy even if you have health insurance. The drug manufactured by Chimerix is in early development stages and unapproved by the Food and Drug Administration (FDA). The Hardy family had to file a compassionate use request with the company asking for the experimental drug. In many cases, companies provide experimental drugs. “The FDA approved 974 compassionate use arrangements in fiscal year 2013,” according to CNN.

Chimerix president and CEO Kenneth Moch originally denied the Hardy family’s request saying that if he gave Josh the drug he’d have to help others like him and this would slow down the drug’s approval process.

Early in the drug’s development, the company responded to these types of requests but two years ago the CEO decided that his 54-person company needed to stop focusing its efforts on compassionate use requests (which typically cost them $50,000 a patient) and move forward full force on earning FDA approval.

The Hardys and their army of supporters wouldn’t taking no for an answer. They started a Change.org petition and launched a Save Josh Facebook page that has over 18,000 fans. Thousands of Tweets flooded the Twittersphere demanding that Chimerax release the drug.

Moch was moved and yesterday he opted to make the drug available to Josh and others.

“I’m happy for Josh and I’m happy for many patients,” Moch told CNN. “We’ve come up with a way of helping not just Josh, but helping other patients in need, and there are many.”